Novel Baroreflex Activation Therapy in Resistant Hypertension Results of a European Multi-Center Feasibility Study

Novel Baroreflex Activation Therapy in Resistant Hypertension Results of a European Multi-Center Feasibility Study
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DOI:
10.1016/j.jacc.2010.03.089
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发表时间:
2010-10-05
影响因子:
24
通讯作者:
de Leeuw, Peter W.
de Leeuw, Peter W.
中科院分区:
医学1区
文献类型:
--
作者:
Scheffers, Ingrid J. M.;Kroon, Abraham A.;de Leeuw, Peter W.

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目的评价一种新型植入型装置治疗顽固性高血压患者的安全性和有效性。背景:尽管已有有效的降压药,但仍有相当比例的患者保持高血压。一种新的植入式设备(Rheos系统,CVRx,Inc.,明尼苏达州明尼阿波利斯市)可以激活颈动脉压力感受器反射,可能对这些患者有帮助。方法45名患者,尽管至少服用了3种降压药,但收缩压和舒张压均为160 mm Hg或90 mm Hg,参加了一项前瞻性的非随机可行性研究,以评估Rheos治疗是否可以安全地降低血压。对受试者进行了长达2年的随访。结果基线平均血压179/105 mm Hg,心率80次/min,中位数为5种降压药物。治疗3个月后,平均血压下降21/12 mm Hg。这一结果在17名完成2年随访的受试者中持续,平均减少33/22毫米汞柱。结论Rheos装置可持续降低接受多种药物治疗的难治性高血压患者的血压。这种独特的疗法为这些高危受试者提供了一种安全的个性化治疗选择。这一新方法对顽固性高血压患者有希望,目前正在进行一项前瞻性的安慰剂对照临床试验。(J Am Coll心脏ol 2010;56:1254-8)(C)2010,美国心脏病学会基金会
Objectives This study assessed the safety and efficacy of a novel implantable device therapy in resistant hypertension patients.Background Despite the availability of potent antihypertensive drugs, a substantial proportion of patients remain hypertensive. A new implantable device (Rheos system, CVRx, Inc., Minneapolis, Minnesota) that activates the carotid baroreflex may help these patients.Methods Forty-five subjects with systolic blood pressure >= 160 mm Hg or diastolic >= 90 mm Hg despite at least 3 antihypertensive drugs were enrolled in a prospective, nonrandomized feasibility study to assess whether Rheos therapy could safely lower blood pressure. Subjects were followed up for as long as 2 years. An external programmer was used to optimize and individualize efficacy.Results Baseline mean blood pressure was 179/105 mm Hg and heart rate was 80 beats/min, with a median of 5 antihypertensive drugs. After 3 months of device therapy, mean blood pressure was reduced by 21/12 mm Hg. This result was sustained in 17 subjects who completed 2 years of follow-up, with a mean reduction of 33/22 mm Hg. The device exhibited a favorable safety profile.Conclusions The Rheos device sustainably reduces blood pressure in resistant hypertensive subjects with multiple comorbidities receiving numerous medications. This unique therapy offers a safe individualized treatment option for these high-risk subjects. This novel approach holds promise for patients with resistant hypertension and is currently under evaluation in a prospective, placebo-controlled clinical trial. (J Am Coll Cardiol 2010;56:1254-8) (C) 2010 by the American College of Cardiology Foundation